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Just another Cancercenter.cc Blogs weblogThu, 08 Dec 2016 17:21:54 +0000en-UShourly1https://wordpress.org/?v=4.6.1Should HER2 Testing Be Routinely Performed in Patients with Gastric Cancer?http://kahlertregionalcancer.org/should-her2-testing-be-routinely-performed-in-patients-with-gastric-cancer/
http://kahlertregionalcancer.org/should-her2-testing-be-routinely-performed-in-patients-with-gastric-cancer/#respondThu, 08 Dec 2016 00:01:39 +0000http://yourcanceralliance.cancercenter.cc/should-her2-testing-be-routinely-performed-in-patients-with-gastric-cancer/The short answer is yes! New evidence-based guidelines for human epidermal growth factor receptor 2 (HER2) testing in advanced gastric and gastroesophageal adenocarcinoma (GEA) have been released jointly by the College of American Pathologists (CAP), American Society for Clinical Pathology (ASCP), and American Society of Clinical Oncology (ASCO).

Currently, HER2 is the only marker that can be used to guide treatment choices in advanced GEA. Testing for HER2 may help identify individual patients who could benefit from targeted therapy with the anti-HER2 monoclonal antibody Herceptin®, (trastuzumab). Research suggests that adjunctive therapy with Herceptin may increase overall survival in advanced GEA compared with chemotherapy alone.1

Herceptin is a targeted therapy that has made important contributions to improved outcomes among women with HER2-positive breast cancer. HER2 is also overexpressed in some stomach cancers. The HER2 pathway is a biological pathway involved in cellular replication and growth. Herceptin targets and blocks the HER2-protein and is used for the treatment of both early-stage and more-advanced HER2-positive cancers.

The guidelines were published online November 14 in the Archives of Pathology & Laboratory Medicine, American Journal of Clinical Pathology, and Journal of Clinical Oncology.2

A key point about the new guidelines is that they recommend HER2 testing during the initial diagnosis of advanced GEA and at important other points during treatment. The guidelines point out that the evidence does not support HER2 testing in patients with resectable tumors. They acknowledge that not all patients with advanced GEA may be candidates for anti-HER2 therapy, and advise that HER2 testing not be required in such patients. When the HER2 status is unclear because of technical issues, such as inadequate tissue sampling, additional tumor sampling may be pursued if it can be done safely.

Bartley A, Washington M, Colasacco C, et al. HER2 Testing and Clinical Decision Making in Gastroesophageal Adenocarcinoma: Guideline From the College of American Pathologists, American Society for Clinical Pathology, and the American Society of Clinical Oncology. DOI: 10.1200/JCO.2016.69.4836 Journal of Clinical Oncology– published online before print November 14, 2016

]]>http://kahlertregionalcancer.org/should-her2-testing-be-routinely-performed-in-patients-with-gastric-cancer/feed/0ASCO Recommends Early Integration of Palliative Care for Advanced Cancershttp://kahlertregionalcancer.org/asco-recommends-early-integration-of-palliative-care-for-advanced-cancers/
http://kahlertregionalcancer.org/asco-recommends-early-integration-of-palliative-care-for-advanced-cancers/#respondMon, 05 Dec 2016 00:01:48 +0000http://yourcanceralliance.cancercenter.cc/asco-recommends-early-integration-of-palliative-care-for-advanced-cancers/The American Society of Clinical Oncology (ASCO) has updated its guidelines on the integration of palliative care for patients diagnosed with advanced cancer, as well as their caretakers. In essence, the guidelines state that palliative care should be administered as early as possible for all patients diagnosed with advanced cancers, alongside their active treatment, as part of their care. The updated guidelines were recently published in the Journal of Clinical Oncology.

The definition of palliative care used for oncology patients, adopted by the National Consensus Project, is the following: “Palliative care means patient and family-centered care that optimizes quality of life by anticipating, preventing, and treating suffering. Palliative care throughout the continuum of illness involves addressing physical, intellectual, emotional, social, and spiritual needs and to facilitate patient autonomy, access to information, and choice.”

Historically, palliative care was often reserved for patients who suffered from symptoms caused by their cancer and/or were at the end of their lives. However, more recently, palliative care has been recognized to improve numerous aspects of quality of life for cancer patients and their caregivers, and is now being evaluated for its possible benefits in earlier-stages of the disease.

According to ASCO, palliative care for cancer includes the following aspects of care:

Open discussions and relationship-building with the patient and family caregivers

Assessment and support of needs for healthy coping, such as maintaining dignity

Assistance with medical decision-making

Coordination of care or assistance with other care providers

Referrals to other care providers, as needed

The updated guidelines were set forth following extensive review of data and clinical trials exploring outcomes associated with palliative care administered to patients with advanced cancer, as well as their family and caregivers. An Expert Panel was convened that included healthcare providers from multiple disciplines to objectively interpret the evidence of published results.

Overall, palliative care demonstrated a significant improvement in quality of life measures for patients, whether the patients were admitted to the hospital, or were receiving outpatient treatment. Furthermore, family members and caregivers of patients also demonstrated an improvement in their quality of life as caretakers to the patient with the integration of dedicated palliative care to the patient.

Due to the overwhelming positive outcomes associated with integration of palliative care alongside active treatment for patients with advanced cancer, with no detectable negative outcomes associated with palliative care measures, the panel determined the following 5 recommendations:

“Palliative care for patients with advanced cancer should be delivered through interdisciplinary palliative care teams, with consultation available in both outpatient and inpatient settings;

Patients with advanced cancer should be referred to interdisciplinary palliative care teams (consultation) that provide inpatient and outpatient care early in the course of disease, alongside active treatment of their cancer. For newly diagnosed patients with advanced cancer, the Expert Panel suggests early palliative care involvement, starting early in the diagnosis process and ideally within 8 weeks of diagnosis;

Among patients with cancer with high symptom burden and/or unmet physical or psychosocial needs, outpatient programs of cancer care should provide and use dedicated resources (palliative care clinicians) to deliver palliative care services to complement existing program tools;

For patients with early or advanced cancer for whom family caregivers will provide care in outpatient, home, or community settings, nurses, social workers, or other providers may initiate caregiver-tailored palliative care support, which could include telephone coaching, education, referrals, and face-to-face meetings. For family caregivers who may live in rural areas and/or are unable to travel to clinic and/or longer distances, telephone support may be offered;

Interventional studies support early specialty palliative care referrals among patients with advanced-stage malignancies and their caregivers.”

According to the 2016 updated ASCO guidelines, the Expert Panel issued the following final determination that included palliative care into the standard treatment guidelines for patients with advanced cancer: “Inpatients and outpatients with advanced cancer should receive dedicated palliative care services, early in the disease course, concurrent with active treatment. Referral of patients to interdisciplinary palliative care teams is optimal, and services may complement existing programs. Providers may refer family and friend caregivers of patients with early or advanced cancer to palliative care services.”

Patients diagnosed with advanced cancer, loved ones of patients with advanced cancer, and/or caretakers of patients with advanced cancer should ensure they receive referrals to the appropriate palliative care specialists. As stated within the recommendations, dedicated palliative care services should ideally be initiated within 8 weeks of the diagnosis of advanced cancer.

]]>http://kahlertregionalcancer.org/asco-recommends-early-integration-of-palliative-care-for-advanced-cancers/feed/0Cabometyx™ Improves Time to Cancer Progression as Initial Therapy in Kidney Cancerhttp://kahlertregionalcancer.org/cabometyx-improves-time-to-cancer-progression-as-initial-therapy-in-kidney-cancer/
http://kahlertregionalcancer.org/cabometyx-improves-time-to-cancer-progression-as-initial-therapy-in-kidney-cancer/#respondMon, 05 Dec 2016 00:01:41 +0000http://yourcanceralliance.cancercenter.cc/cabometyx-improves-time-to-cancer-progression-as-initial-therapy-in-kidney-cancer/The agent Cabometyx™ (cabozantinib) improves anti-cancer responses and time to cancer progression compared to Sutent® (sunitinib) when used as initial therapy for advanced kidney cancer. These results were recently published in the Journal of Clinical Oncology.

The kidneys are a pair of organs with multiple functions. Renal cell carcinoma is the most common type of kidney cancer. Metastatic renal cell carcinoma (mRCC) refers to cancer that has spread from the kidney to distant sites in the body.

Cabozantinib is an agent that inhibits pathways within cells that are implicated with the growth and spread of cancer. Specifically, cabozantinib is thought to inhibit the VEGF2, MET, and AXL pathways. Cabozantinib is already approved for the treatment of mRCC that has stopped responding to prior standard therapies.

Researchers recently conducted a clinical trial to compare treatment with cabozantinib to sunitinib, an agent that is currently approved as initial therapy for mRCC. The trial included 157 patients with poor- or intermediate-risk (at a high or intermediate risk for a cancer recurrence following therapy) who had not received prior therapy. Patients were divided into two groups: one group was treated with cabozantinib, and the other group was treated with sunitib.

Anti-cancer responses were achieved in 46% of patients treated with cabozantinib, compared with 18% for those treated with sunitinib.

The median time of survival without progression of cancer was 8.2 months for patients treated with cabozantinib, compared with 5.6 months for those treated with sunitinib.

Overall, patients treated with cabozantinib had a 34% reduction in the rate of cancer progression or death, compared to those treated with sunitinib.

Severe side effects occurred in 67% of patients treated with cabozantnib, and 68% of patients treated with sunitinib.

The researchers concluded that “Cabozantinib demonstrated a significant clinical benefit in PFS and ORR over standard-of-care sunitinib as first-line therapy in patients with intermediate- or poor-risk mRCC.”

]]>http://kahlertregionalcancer.org/cabometyx-improves-time-to-cancer-progression-as-initial-therapy-in-kidney-cancer/feed/0Duration of Blood Storage Does Not Affect Outcomes for Patients Requiring Blood Transfusionshttp://kahlertregionalcancer.org/duration-of-blood-storage-does-not-affect-outcomes-for-patients-requiring-blood-transfusions/
http://kahlertregionalcancer.org/duration-of-blood-storage-does-not-affect-outcomes-for-patients-requiring-blood-transfusions/#respondThu, 01 Dec 2016 00:01:04 +0000http://yourcanceralliance.cancercenter.cc/duration-of-blood-storage-does-not-affect-outcomes-for-patients-requiring-blood-transfusions/The length of time that blood is stored prior to a blood transfusion, within normal ranges, does not appear to affect mortality among patients requiring transfusions. These results were recently published in the New England Journal of Medicine.

Many patients with cancer require red blood cell transfusions, either in response to the disease itself, or to replenish these cell levels after treatment. Following the collection of blood from a donor or patient, it is stored according to specifications prior to a transfusion.

Although blood cannot safely be stored indefinitely prior to a transfusion, the duration of its storage and its possible impact on outcomes was recently evaluated through a large clinical trial including 6 hospitals in 4 countries. The trial included nearly 21,000 patients with either A or O blood types who received a red blood cell transfusion. One group of patients received blood with a median storage time of 13.0 days prior to transfusion (short-term storage group), and a second group of patients received blood with a median storage time of 23.6 days prior to transfusion (long-term storage group).

Overall, there were no differences in rates of mortality following the transfusion between patients in the short-term or long-term storage groups.

Although this trial was designed to evaluate the general population of patients in a hospital setting, one pre-specified high-risk group was cancer patients. There were also no differences in rates of mortality following a transfusion between cancer patients in the short-term or long-term storage groups.

The researchers concluded that “there was no significant difference in the rate of death among those who underwent transfusion with the freshest available blood and those who underwent transfusion according to the standard practice of transfusing the oldest available blood.” These results confirm prior results evaluating cancer patients receiving transfusions with differing storage times of blood.

]]>http://kahlertregionalcancer.org/duration-of-blood-storage-does-not-affect-outcomes-for-patients-requiring-blood-transfusions/feed/0Darzalex® Approved for Additional Indications in Multiple Myelomahttp://kahlertregionalcancer.org/darzalex-approved-for-additional-indications-in-multiple-myeloma/
http://kahlertregionalcancer.org/darzalex-approved-for-additional-indications-in-multiple-myeloma/#respondTue, 29 Nov 2016 00:01:46 +0000http://yourcanceralliance.cancercenter.cc/darzalex-approved-for-additional-indications-in-multiple-myeloma/The United States Food and Drug Administration (FDA) has approved Darzalex® (daratumumab) for the treatment of multiple myeloma among patients who have received at least one prior therapy. The new FDA indication also requires that daratumumab be used in combination with lenalidomide and dexamethasone, or in combination with bortezomib and dexamethasone.

Daratumumab is already approved for use as a single agent for multiple myeloma among patients who have received at least 3 prior treatments including a proteasome inhibitor (PI) and an immunomodulatory agent, or among those who have stopped responding to both of these types of treatment.

Multiple myeloma is considered a type of blood cancer, and is characterized by an excess proliferation of certain cells in the immune system called plasma cells. In 2016, it is estimated that approximately 30,330 new patients will be diagnosed with multiple myeloma in the United States, and approximately 12,650 people are expected to die from the disease. Once patients with multiple myeloma experience cancer progression following standard therapies, prognosis remains poor.

Daratumumab is an agent that targets a specific molecule called CD38, which is found in large quantities on the surface of multiple myeloma cells. Daratumumab binds to CD38, and through a series of responses by the body, death occurs to the cells to which daratumumab binds.

The clinical trials prompting the latest daratumumab approval are referred to as the CASTOR and POLLUX studies. The CASTOR trial included nearly 500 patients with multiple myeloma that had returned or stopped responding to prior therapy. One group of patients in the trial was treated with daratumumab plus bortezomib and dexamethasone; a second group of patients was treated with bortezomib and dexamethasone (a standard treatment regimen). Outcomes between the two treatment groups were directly compared.

Anti-cancer responses were achieved in 79% of patients treated with daratumumab/bortezomib/dexamethasone, compared with 60% for patients treated with bortezomib/dexamethasone only.

The median time to progression of cancer has not yet been reached among the group of patients treated with daratumumab/bortezomib/dexamethasone, compared with 7.2 months for those treated with bortezomib/dexamethasone only.

The POLLUX study included nearly 570 patients whose cancer had progressed or stopped responding to standard therapy. One group of patients in this trial was treated with daratumumab plus lenalidomide and dexamethasone; a second group of patients was treated with lenalidomide and dexamethasone (a standard treatment regimen). Outcomes between the two treatment groups were directly compared.

Anti-cancer responses were achieved in 91% of patients treated with daratumumab/lenalidomide/dexamethasone, compared with 75% for patients treated with lenalidomide/dexamethasone only.

Patients treated with daratumumab/lenalidomide/dexamethasone had a 63% reduced rate of cancer progression at the time of the last update of the trial, compared to those treated with lenalidomide/dexamethasone only.

Patients with multiple myeloma that have stopped responding to standard therapies now have additional treatment options available that continue to improve the outcomes of this disease.

]]>http://kahlertregionalcancer.org/darzalex-approved-for-additional-indications-in-multiple-myeloma/feed/0Opdivo Approved for Advanced Head and Neck Cancerhttp://kahlertregionalcancer.org/opdivo-approved-for-advanced-head-and-neck-cancer/
http://kahlertregionalcancer.org/opdivo-approved-for-advanced-head-and-neck-cancer/#respondMon, 28 Nov 2016 00:01:36 +0000http://yourcanceralliance.cancercenter.cc/opdivo-approved-for-advanced-head-and-neck-cancer/The United States Food and Drug Administration (FDA) has approved the immunotherapeutic agent, Opdivo® (nivolumab) for the treatment of advanced head and neck cancer. Specifically, the indication is for the treatment of squamous cell carcinoma of the head and neck cancer (SCCHN) that has spread to distant sites in the body and has progressed or recurred following prior therapy with a platinum-based chemotherapy agent.

Head and neck cancer refers to cancer that originates in areas of the head or neck, including the throat, voice box, mouth, salivary glands, lips, nasal cavity, and sinuses. Squamous cells are the types of cells that line the moist surfaces of these locations, from which cancer may arise.

Opdivo is an agent that helps the immune system identify cancer cells, and mount an attack against them. Opdivo is already approved for several different types of cancers, including certain types of lung cancer, melanoma, kidney cancer, and Hodgkin’s disease.

The latest approval for Opdivo in SCCHN was based on results from a clinical trial referred to as the Checkmate 141 trial. It included 361 patients with SCCHN that had spread outside of the head or neck, or had progressed within 6 months of platinum-based chemotherapy. Patients on the trial were divided into two treatment groups: one group was treated with nivolumab, and the second group was treated with standard therapy. The median time of overall survival was 7.5 months for patients treated with Opdivo, compared with 5.1 months for those treated with standard therapy.

Patients with advanced SCHHN whose cancer has progressed following prior therapy with cisplatin or carboplatin now have an additional treatment option for their disease. Patients whose SCHHN has recurred may wish to speak with their physician regarding their individual risks and benefits of treatment with Opdivo.

Full prescribing information for Opdivo can be found at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125554s022lbl.pdf.

]]>http://kahlertregionalcancer.org/opdivo-approved-for-advanced-head-and-neck-cancer/feed/0It’s GERD Awareness Week–November 20thhttp://kahlertregionalcancer.org/its-gerd-awareness-week-november-20th/
http://kahlertregionalcancer.org/its-gerd-awareness-week-november-20th/#respondSun, 20 Nov 2016 00:01:18 +0000http://yourcanceralliance.cancercenter.cc/its-gerd-awareness-week-november-20th/It’s that time of year again when there is a tendency to overindulge in a mélange of delicious foods. Although many people may only suffer discomfort from over eating, another group of people suffer from the far more troublesome and chronic disorder of GERD—and it isn’t just over the holidays, nor is it simply from over-eating or poor choice of diet.

GERD (gastroesophageal reflux disease) is a chronic disease where stomach contents flow back into the esophagus causing painful or uncomfortable symptoms and possible damage to the esophagus. Symptoms arise after food is eaten and is in the stomach. The acid reflux occurs when the muscle barrier that is between the stomach (the lower esophageal sphincter, or LES) and the esophagus doesn’t work properly, and the acid makes its way up into the esophagus.

Although certain behaviors may increase your risk of developing GERD, there is no known single cause of GERD—there are many. In fact, many cancer patients may experience GERD after treatment with chemotherapy. GERD is also a common side effect of rheumatoid arthritis treatment.

The good news for these patients and for others with this chronic disease is that long-term medication therapy is usually effective. If medication is not effective, surgery is an option. There are also lifestyle changes that can help you manage your symptoms.

If you have any of the following symptoms, be sure to get a check-up with your doctor:

Your heartburn happens 2 or more times a week

Your heartburn gets worse

Your heartburn wakes you from sleep at night

You’ve had heartburn now and then for several years

You have difficulty or pain when swallowing

Your discomfort interferes with daily activities

A proper diagnosis from your doctor not only can get you on the road to recovery, but it may keep you from future complications down the road—if GERD goes on for too long unchecked and not treated, it can lead to Barrett’s esophagus and esophageal cancer. To learn more about the risk factors of esophageal cancer, go here.

Appropriately, GERD Awareness Week is reserved for the week of Thanksgiving each year when people experience higher than average bouts of heartburn. To find out more about GERD visit the GIConnection, or get involved with a GERD online community.

]]>http://kahlertregionalcancer.org/its-gerd-awareness-week-november-20th/feed/0FDA Priority Review Granted for Midostaurin in Leukemiahttp://kahlertregionalcancer.org/fda-priority-review-granted-for-midostaurin-in-leukemia/
http://kahlertregionalcancer.org/fda-priority-review-granted-for-midostaurin-in-leukemia/#respondThu, 17 Nov 2016 00:01:53 +0000http://yourcanceralliance.cancercenter.cc/fda-priority-review-granted-for-midostaurin-in-leukemia/The United States Food and Drug Administration (FDA) has granted priority review to PKC412 (midostaurin) in the treatment of newly diagnosed acute myeloid leukemia (AML) with the FLT3 mutation, as well as for the treatment of advanced systemic mastocytosis (SM). The diagnostic test to detect the FLT3 mutation has also been accepted for review by the FDA.

Acute myeloid leukemia is an aggressive type of leukemia, resulting from the abnormal and stunted development of a certain type of immune cell. AML comprises approximately 25% of all types of leukemia cases worldwide. The FMS-like tyrosine kinase-3 (FLT3) mutation is found in approximately one-third of AML diagnoses, and is associated with poorer outcomes than standard-risk AML. An average of 25% of patients diagnosed with AML will survive 5 years following diagnosis when treated with standard therapies, necessitating the development of novel therapeutic approaches.

Systemic mastocytosis is a rare disease in which the body produces an abundance of mast cells – cells which normally serve as mediators in allergic responses. The mast cells accumulate in the body’s organs, disrupting their ability to function normally. Survival times for SM are largely dependent upon the subtype of disease, but remain suboptimal with standard therapies. Patients often suffer from symptoms such as severely itchy skin due to the histamine released by the mast cells.

PKC412 is an agent that blocks multiple pathways within cells that are responsible for growth and replication of cells. These types of pathways often have a mutation in cancer cells, which lead to the uncontrolled and rapid growth and replication that is abnormal when compared to a healthy cell.

Two clinical trials prompted the FDA responses to PKC412. One of the trials, the RATIFY trial, was a phase III trial including adults younger than 60 years of age with FLT3-mutated AML. One group of the patients in the trial was treated with standard chemotherapy plus PKC412, and the other group was treated with standard chemotherapy plus placebo (inactive substitute). The two groups were directly compared.

Patients treated with chemotherapy/PKC412 had a 23% reduced risk of death, compared to those treated with chemotherapy/placebo.

The occurrence of serious side effects were not significantly different between the two treatment groups.

The second clinical trial included patients with advanced SM, all of whom received treatment with PKC412.

60% of patients demonstrated a response to PKC412, meaning they achieved a complete or partial resolution of organ damage caused by the disease.

The median duration of time that the response to treatment lasted was 24.1 months, with a median overall survival time of 28.7 months.

The most frequent side effects appear to be mild in nature.

PKC412 is still an investigative agent; however, the new designation by the FDA will result in a shorter review time in which the FDA will provide a decision in regards to PKC412 for the treatment of these two diseases, compared to a standard FDA review timeline for a new drug.

]]>http://kahlertregionalcancer.org/fda-priority-review-granted-for-midostaurin-in-leukemia/feed/0Aromatase Inhibitor–Associated Joint Pain Tends to Resolve Upon Treatment Completionhttp://kahlertregionalcancer.org/aromatase-inhibitor-associated-joint-pain-tends-to-resolve-upon-treatment-completion/
http://kahlertregionalcancer.org/aromatase-inhibitor-associated-joint-pain-tends-to-resolve-upon-treatment-completion/#respondTue, 15 Nov 2016 00:01:02 +0000http://yourcanceralliance.cancercenter.cc/aromatase-inhibitor-associated-joint-pain-tends-to-resolve-upon-treatment-completion/A class of drugs known as aromatase inhibitors (AI) commonly used in the management of estrogen receptor-positive (ER+) breast cancer are associated with troublesome joint pain. In fact, as many as half of women on AI therapy experience joint pain, and 20% become non-compliant with their AI therapy because of side effects.1

The origin of AI-associated joint pain is unclear. There are no effective supportive care therapies to mitigate AI-associated joint pain and premature discontinuation of AI therapy may adversely affect breast cancer outcomes. For women whose joint pain is significantly affecting quality of life, it is important to discuss quality of life factors, side effects and benefits of staying on therapy with their physician in order to make an informed treatment decision.

A recent report of a small number of patients with AI-associated joint pain may provide some insight for women dealing with this side effect. In this study, researchers followed up on a series of 17 patients initially reported on almost 10 years ago. These patients had AI-associated joint paint, and some had arthritis and all had completed AI therapy.2 Upon completion of AI treatment, joint pain disappeared in 10 of the 17 patients within 3 months , and 2 more of the 17 patients had a >50% decrease in joint pain.

Overall two-thirds of the women in this study with AI-associated joint pain had a resolution or improvement of their symptoms once AI therapy was discontinued. The researchers also reported that in a few patients “AI therapy could promote the occurrence of autoimmune disease, persisting despite discontinuation of treatment.”

Importantly, the median time to cancer progression for Lynparza-treated patients substantially exceeded that observed in a previous study in patients with platinum-sensitive relapsed ovarian cancer.2

Each year in the United States, roughly 22,000 women are diagnosed with ovarian cancer and more than 15,000 die of the disease. Treatment for ovarian cancer commonly involves surgery and/or chemotherapy. Researchers continue to study new approaches for improving the outcomes of all women affected by ovarian cancer but progress has been slow.

The PARP enzyme plays a role in DNA repair, including the repair of DNA damage from chemotherapy. Drugs that inhibit this enzyme may contribute to cancer cell death and increased sensitivity to chemotherapy. PARP inhibitors are thought to have the greatest effect in women with mutations of the BRCA genes, who represent about 15% of ovarian-cancer patients. But recent research, still ongoing, indicates that the drugs may benefit an additional 35% of patients with different genetic profiles.

Lynparza constitutes the first PARP inhibitor approved for treating ovarian cancer. Lynparza was approved for patients with specific abnormalities in the BRCA gene and is an example of how a greater understanding of the underlying mechanisms of disease can lead to targeted, more personalized treatment.1

The FDA approved Lynparza3 with a genetic test called BRACAnalysis CDx, a companion diagnostic that will detect the presence of mutations in the BRCA genes (gBRCAm) in blood samples from patients with ovarian cancer. The BRCA genes are involved with repairing damaged DNA and normally work to suppress tumor growth. Women with mutations resulting in defective BRCA genes are more likely to get ovarian cancer, and it is estimated that 10 to 15 percent of all ovarian cancer is associated with these hereditary BRCA.